Men with long standing lung diseases such as chronic bronchitis or emphysema or who are overweight

Men who stop breathing temporarily during sleep known as sleep apnoea

They should not be used in:

People with a known hypersensitivity (allergy) to testosterone or any of the ingredients in the medication

Women

Children under 18 years old

Men with male breast cancer

Men with prostate cancer or an enlarged prostate gland

Also see list of precautions and interactions

STORAGE

Testosterone undecanoate capsules (Restandol Testocaps) Do not store above 30°C. Do not refrigerate or freeze. Keep the blister in the outer carton.

Testosterone 300 µg patches (Intrinsa) Do not store above 30°C. Do not refrigerate or freeze.

Testosterone for IM injection (Nebido) This medicinal product does not require any special storage conditions.

Testosterone for IM injection (Sustanon) Do not store above 25°C. Do not refrigerate or freeze. Store the ampoules in the outer carton

Testosterone enanthate for IM injection Protect from the light.

Testosterone propionate for IM injection (Virormone) Do not store above 25°C. Protect from light. Store in the original container.

Testosterone implant Do not store above 25°C. Store in the original package.

Testosterone gel (Testim) Do not store above 25°C.

Testosterone gel (Testogel) This medicinal product does not require any special storage conditions

Testosterone gel (Tostran) Do not store above 25°C. Do not refrigerate

TESTOSTERONE USES

What is it used for?

Testosterone is used to replace naturally occurring testosterone in men with low levels and help the reproductive system to function normally. It is also used to treat certain other conditions in women.

It is a steroid hormone, sometimes known as male sex hormone or androgen.

It is used to treat a variety of conditions involving the male and female reproductive system. Testosterone is a natural male hormone, which is produced mainly by the testes in males and by the ovaries in females. Testosterone is used to increase the level of testosterone (testosterone replacement therapy) in men with low levels of natural testosterone (hypogonadism). A lack of testosterone can cause impotence, low sexual desire (libido), tiredness, depression, a reduction in male sexual characteristics such as body hair and deep voice, problems with sperm production and weak bones (osteoporosis). The low levels of testosterone may be due to a variety of reasons such as castration (removal of testes) or hormonal problems in the testes or pituitary gland. It is also used in women to treat breast cancer (only after the menopause), in female to male sex changes, and to treat post-menopausal symptoms as hormone replacement therapy).

In general this drug is used to replace testosterone (testosterone replacement therapy) in men with low natural levels of testosterone and to improve male sexual characteristics including sexual functioning and sexual desire.

Benefits of being on this drug can include improvements in sexual functioning and sexual desire.

Listed below are the typical uses of testosterone. The uses depend on the formulation used.

Males uses:

Testosterone replacement therapy due to low natural testosterone arising from castration or lack of testes, or disease of the pituitary gland or testes (hypogonadism)

On occasion your doctor may prescribe this medicine to treat a condition not on the above list. Such conditions are listed below.

None known

HOW TO USE/TAKE

How often do I take it? >

Testosterone is available in a variety of forms: as oral capsules, skin patches, ampoules for injection, as an implant and as gels. It is available as testosterone and as testosterone esters (such as testosterone undecanoate, testosterone propionate) which release testosterone into the body.

Testosterone undecanoate capsules (Restandol Testocaps) Take this medication by mouth, usually twice daily with food. It is best to take half of the daily dose in the morning and the other half in the evening. Swallow the capsules whole without chewing.

Testosterone 300 µg patches (Intrinsa) - female use only Take this medication by applying the patch to the skin of your lower abdomen, usually twice weekly and keep it on for about 3 to 4 days before replacing it with a fresh patch. Directions for using the patches are given in the Patient Information Leaflet. The patches must be used with oestrogen therapy.

Testosterone by IM injection (Nebido) This medication will be given to you as an injection into a muscle by a doctor or nurse, usually every 10 to 14 weeks.

Testosterone by IM injection (Sustanon) This medication will be given to you as an injection into a muscle by a doctor or nurse, usually one injection every 3 weeks.

Testosterone enanthate ampoules for IM injection This medication will be given to you as an injection into a muscle by a doctor or nurse, usually every 2 to 3 weeks. The frequency of dosing depends on the condition for which you are being treated.

Testosterone implant This medication will be given to you as subcutaneous implant (beneath the skin) by a doctor using a local anaesthetic. The effect of the implant lasts for about 4 to 5 months.

Testosterone gels (Tostran, Testogel, Testim) Take this medication by applying the gel to your skin of your lower abdomen, inner thighs or shoulders and upper arms, usually once daily. Directions for using the gel are given in the Patient Information Leaflet.

Use this medication regularly in order to get the most benefit from it.

It may take up to a few months before the full benefit of this drug takes effect.

Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

Testosterone is not known to affect driving or operating machinery.

Testosterone patches: You may shower and bathe with the patch on, but avoid rubbing it too much.

Testosterone gels: Take care to avoid transferring your gel to anyone else during personal contact by covering the application site with loose clothing, or by showering or bathing prior to contact. It is particularly important to avoid transfer to women and children. Avoid sexual intercourse for a long period of time after applying the gel to prevent transfer to your partner.

Testosterone given by IM injection (Nebido) common side effects include:

Acne

Injection site pain

Large increases in red blood cell count

Weight gain

Hot flush

Prostate problems including enlarged prostate and prostate cancer

Testosterone given by IM injection (Sustanon) common side effects include:

Worsening of the early stages of prostate cancer

Acne

Prolonged and painful erection

High blood pressure

Increases in sexual desire (libido)

Hoarse voice

Changes in sperm formation

Swollen ankles (due to fluid retention)

Large increases in the red blood cell count

Changes in liver enzymes

Similar side effects are seen with testosterone enanthate and testosterone propionate (Virormone) given by IM injection. Women treated with these medications for breast cancer may develop acne, increased facial hair, head hair loss and a deep voice.

Common side effects seen with the use of testosterone gels (Tostran, Testim and Testogel) include:

Application site reactions including itching, rash and redness

High blood pressure

Headache

Acne

Increases in the blood of prostatic specific antigen (PSA) produced by the prostate gland

Large increases red blood cell count

Swelling of hands and feet

Loss of head hair

Increased body hair growth

Breast enlargement

Flushing

When testosterone is given to boys, it may lead to early sexual development and delayed bone growth.

If any of these persist or you consider them severe then inform your doctor or pharmacist. Application skin reactions including itching, irritation, burning, rash and redness or blisters - stop taking if the reaction is severe.

Tell your doctor immediately if you develop any of the following symptoms:

Breathing abnormalities including any during sleep

Prolonged and painful erections of your penis

Swelling of your ankles

Changes in skin colour

Feeling irritable or nervous

Gain weight

Nausea or vomiting

A change in the frequency with which you need to urinate or the appearance of the urine

Yellowing of your skin and whites of your eyes

Women: Hair loss, enlargement of the clitoris, an increase in the amount of facial hair or your voice deepening or becoming hoarse with use of testosterone 300 µg patches (Intrinsa).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.

TESTOSTERONE PRECAUTIONS

Before taking testosterone, tell your doctor or pharmacist if you are allergic to it; or to other androgens; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of:

Hypersensitivity (allergy) to testosterone or to any of the ingredients in the medication

Peanut allergy (IM injection- Sustanon only)

Male breast cancer

Known or suspected prostate cancer

For some formulations if you have:

Or have had liver tumours

High blood or urine calcium levels (hypercalcaemia or hypercalciuria)

Kidney damage (nephrotic syndrome)

Enlarged prostate gland

Before using this medication tell your doctor or pharmacist your medical history, especially any of the following

Long standing lung diseases such as chronic bronchitis or emphysema or are overweight

Interrupted breathing during sleep known as sleep apnoea

Any skin problems (if testosterone is applied to the skin)

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

Alcohol is not known to affect testosterone.

The elderly: testosterone should be used with caution in elderly men as they are at a higher risk of developing prostate problems and swelling due to fluid retention (oedema). Testosterone 300 µg patches (Intrinsa) are only to be used in surgically menopausal women up to the age of 60.

PREGNANCY

Testosterone is not safe to take if you are, or are planning to become, pregnant.

BREAST FEEDING

Testosterone is not safe to take if you are breastfeeding.

TESTOSTERONE INTERACTIONS

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur: None known

Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

Testosterone may interfere with some laboratory tests such as those for glucose tolerance and thyroid function.

This information does not contain all possible interactions. Therefore, before using testosterone, tell your doctor or pharmacist of all the products you use.

TESTOSTERONE OVERDOSE

Testosterone undecanoate capsules (Restandol Testocaps) If you have taken several capsules at once, there is no need for great concern, however you should tell your doctor. The castor oil in the capsule may cause diarrhoea.

Testosterone 300 µg patches (Intrinsa) If you have applied more than one patch at a time Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with the medication. Overdosing is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body.

Testosterone given by IM injection Overdose with testosterone can cause irritability, nervousness, weight gain and long-lasting or frequent erections. Tell your doctor, if you have any of these. Your doctor will inject it less often or will stop treatment.

Testosterone implant Overdose can cause prolonged and painful periods and deepening voice in women. See your doctor to remove the implant.

Testosterone gels If you have applied too much gel, contact a doctor, hospital or pharmacist. Overdose with testosterone gel can cause irritability, nervousness, weight gain and prolonged or frequent erections. If you get these symptoms with normal use, it may indicate that you need your dose adjusting.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of testosterone or intentional overdose is suspected, contact your local hospital, GP or if in England call NHS 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.

MISSED DOSE

Testosterone undecanoate capsules (Restandol Testocaps)

If you miss the morning dose and it is more than 2 hours after breakfast, wait until lunch-time and then take the dose. If you miss the evening dose, and it's more than 2 hours after dinner, do not take the missed dose. Take the next morning dose as normal.

Testosterone 300 µg patches (Intrinsa)

Change your patch as soon as you remember, and then continue with your regular schedule of patch change days, even if this means discarding a patch after you have worn it for less than 3 to 4 days. Returning to your regular schedule will help you remember when to change your patch.

Testosterone gels

If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

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Selected from data included with permission and copyrighted by Boots UK Limited or TicTac Communications Ltd. This copyrighted material is sourced from a licensed data provider and is not for distribution, except as may be authorised by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgement of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse events, nor should it be construed to indicate that use of a particular medicine is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any medicine, changing any diet, or discontinuing any course of treatment.

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